AccessGUDID - DEVICE: Link Embrace Shoulder System

GUDID

Device Identifier (DI) Information

Brand Name: Link Embrace Shoulder System - Instruments
Version or Model: 645-004/15
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: WALDEMAR LINK GmbH & Co. KG

Primary DI Number: 04026575280049
Issuing Agency: GS1
Commercial Distribution End Date: March 08, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 315675488 *Terms of Use

Device Description: Shoulder glenoid fossa prosthesis trial - LINK Embrace Shoulder System

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60932	Shoulder glenoid fossa prosthesis trial	A copy of a final shoulder glenoid fossa prosthesis designed to be used before primary or revision implant surgery to validate the proper size of the permanent prosthesis required by the patient and to ensure its proper orientation and positioning. It is cup-like in shape and typically made of metal and/or polymer. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HWT	TEMPLATE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5fd9bc78-f34e-445d-bf17-fe477f49c449
Public Version Date: March 20, 2024
Public Version Number: 2
DI Record Publish Date: December 15, 2022